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NEWS

FDA Grants Accelerated Approval to Replimune’s Tudriqev + Opdivo for Unresectable Cutaneous Melanoma Progressed on Anti-PD-1 Based Regimen

Shots: FDA has granted accelerated approval to Tudriqev (vusolimogene oderparepvec-wtpg or RP1) + nivolumab for adults with unresectable advanced cutaneous melanoma whose disease progressed on an anti-PD-1 antibody-based regimen P-II (IGNYTE) trial enrolled 140 pts, with 91 efficacy-evaluable pts having ≥1 non-injected lesion. Tudriqev + nivolumab achieved a 24.2% ORR & an mDoR of 14.1mos., with results…
4 days ago

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NEWS

Henlius Reports First Patient Dosing in P-I Trial of HLX18 (Biosimilar, Opdivo) in China 

Shots:  Henlius has dosed the first patient in China in the P-I (HLX18-MRST001) trial assessing its nivolumab biosimilar, HLX18, in patients with resected solid tumors  The study will compare HLX18 vs. Opdivo in patients with resected solid tumors, evaluating PK similarity, efficacy, safety, and immunogenicity following monotherapy  HLX18 is Henlius' nivolumab biosimilar candidate, developed under global biosimilar guidelines. Reference nivolumab is approved worldwide for multiple cancers, including melanoma, NSCLC, RCC, HCC, urothelial, gastric, esophageal, colorectal, and head & neck cancers  Ref: Henlius  |  Image: Henlius   | Press Release PharmaShots, your go-to media platform for customized news ranging across multiple indications. For more…
July 16, 2026

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NEWS

Orion Pharma Expands Partnership with Shilpa Medicare for Nivolumab Biosimilar in the EU 

Shots:  Orion Pharma has entered into an agreement with Shilpa Biologicals to co-develop and supply IV nivolumab biosimilar across Europe  As per the deal, Orion will gain exclusive rights to register, market, distribute & sell the nivolumab biosimilar across the EU, while Shilpa Biologicals will lead product development, exclusively manufacture & supply the product, and receive development &…
July 6, 2026

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NEWS

Zydus Lifesciences Launches Tishtha (Biosimilar, Opdivo) in India 

    Shots:  Zydus Lifesciences has reported Tishtha, biosimilar version of Opdivo (Nivolumab), is now available in the India  Tishtha will be available in 100 mg and 40 mg strengths  Nivolumab is a mAb targeting PD-1 to enhance anti-tumor immune responses and is approved worldwide for cancers, including melanoma, mesothelioma, head and neck, and urothelial carcinoma   Ref: Zydus  | Image: Zydus |  Press Release  Related News: Shanghai Henlius Receives the US FDA…
January 22, 2026

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NEWS

Shanghai Henlius Receives the US FDA IND Clearance for HLX18 (Biosimilar, Opdivo)  

Shots:  The US FDA has granted IND clearance to HLX18 (nivolumab), a biosimilar version of Opdivo, for the treatment of certain resected solid tumors   Novolumab is an mAb targeting PD-1 to enhance anti-tumor immune responses and is approved worldwide for cancers, including melanoma, mesothelioma, head and neck, and urothelial carcinoma   HLX17 (pembrolizumab biosimilar) and HLX13 (ipilimumab biosimilar) have entered worldwide multicenter P-I…
December 19, 2025

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Biocartis Reports the US FDA’s Approval of Idylla CDx MSI Test to Identify MSI-H Colorectal Cancer Patients

Shots: The US FDA has approved the PMA application for Idylla CDx MSI Test, a cartridge-based, fully automated “sample-to-result” companion diagnostic, with US launch anticipated soon & availability in other non-US markets to follow The Idylla CDx MSI Test helps identify MSI-H colorectal cancer pts eligible for Opdivo (nivolumab) alone or with Yervoy (ipilimumab), as…
September 17, 2025

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NEWS

Xbrane Biopharma and Intas Pharmaceuticals Join Forces to Develop Biosimilar of Opdivo (Nivolumab) 

Shots:  Xbrane and Intas have entered into a global licensing and co-development agreement for Xbrane's biosimilar of Opdivo (nivolumab). Intas, through its Accord Healthcare, will commercialize the biosimilar, leveraging its oncology expertise and significant market presence in the EU  As per the agreement, Intas will fund and manage clinical as well as regulatory development, and…
November 19, 2024

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Viewpoints_Jennifer Fernandez
VIEWPOINTS

TCOC Management in Oncology: Jennifer Fernandez from The Oncology Network in a Dialogue Exchange with PharmaShots

Shots:  Prominent oncology drugs like pembrolizumab and nivolumab were initially approved with weight-based dosing and gradually transitioned to fixed dozing. With the transformation in the dosing model, the average dose amount administered to patients increased dramatically in the Oncology Care Model  Today, at PharmaShots, we have Jennifer Fernandez from The Oncology Network, shedding light on…
August 7, 2024

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